5 August 2014
EMA/305821/2006/Rev.21
Human Medicines Evaluation Division
Checking process of mock-ups and specimens of
outer/immediate labelling and package leaflets of human
medicinal products in the centralised procedure
1. Introduction
Since February 2007 the European Medicines Agency (EMA) has been operating an extensive checking
process of the marketing-authorisation holder’s (MAH) printed packaging materials for outer and
immediate labelling of centrally authorised medicinal products as well as of the printed package leaflet
(‘mock-ups and specimens’).
The EMA has now reviewed the experience with the checking process and considers that further
amendments/simplification can be introduced. This document presents the proposed revision 1 of the
current checking process for human medicinal products, and provides further details on its practical
implementation.
2. General principles
2.1. Labelling and package leaflet requirements
All medicines are required by European law to be accompanied by outer and immediate labelling texts
and a package leaflet setting out comprehensive information which is accessible to and understandable
by those who receive it, so that they can use their medicine safely and appropriately.
Title V of Directive 2001/83/EC defines the particulars to be included on the outer/immediate labelling
and in the package leaflet. Templates are provided in all EEA languages on the EMA website
http://www.ema.europa.eu, which reflect the items which must appear on the labelling and package
leaflet of medicinal products according to the Directive.
1
The revised checking process of mock-ups and specimens of outer/immediate labelling and package leaflets of human medicinal
products in the centralised procedure has been updated to reflect the new address of the European Medicines Agency (section 2.4).
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.
The safe and correct use of all medicines depends (amongst others) on users reading the labelling and
packaging accurately, and being able to understand and act on the information presented. The
primary purpose of labelling and packaging should, therefore, be the clear unambiguous identification
of the medicine and the conditions for its safe use. Applicants/MAHs must make best use of the space
available to ensure that the critical/important information for the safe use of the medicine is legible
and clearly mentioned on prime spaces on the packaging and in the leaflet, so that confusion and
medication errors are minimised.
The ‘Guideline on the readability of the label and package leaflet of medicinal products for human use’,
as published by the European Commission in the Notice to Applicants, Volume 2C
(http://ec.europa.eu/health/documents/eudralex/vol-2/index_en.htm), sets out helpful advice on the
presentation of the content of the labelling and package leaflet (required in accordance with Title V of
Directive 2001/83/EC) and on the design and layout concepts which will aid the production of high
quality information. It is intended to assist applicants and MAHs when drawing up the labelling and
package leaflet and preparing the mock-ups and/or specimens of the sales presentations. The
guideline also includes information on how the requirements for Braille for the labelling and for
‘consultations with target patient groups’ for the package leaflet can be met, as well as how to make
the package leaflet available in formats suitable for the blind and partially sighted patients.
As set-out in Article 57 of Directive 2001/83/EC, a Member State may ask for additional information to
appear on the outer packaging (in a ‘blue box’) concerning identification and authenticity of the
product, the legal category for supply and price/reimbursement. Details on the national requirements
for the ‘blue box’ of centrally authorised medicinal products are given in the ‘Guideline on the
packaging information of medicinal products for human use authorised by the Community’ as published
by the European Commission in the Notice to Applicants, Volume 2C
(http://ec.europa.eu/health/documents/eudralex/vol-2/index_en.htm).
Article 54 (e) of Directive 2001/83/EC requires that the outer packaging must also include a space for
the prescribed dose to be indicated (e.g. to affix the dispensing label or for hand-written pharmacist
instructions).
As stated in Article 61(1) of Directive 2001/83/EC one or more mock-ups of the outer packaging and
the immediate packaging of a medicinal product, together with the draft package leaflet, shall be
submitted to the authorities competent for authorising marketing when the marketing authorisation is
requested. The results of assessments carried out in cooperation with target patient groups shall also
be provided to the competent authority.
The legal provisions within Article 62 of Directive 2001/83/EC permit the use of images, pictograms
and other graphics to aid comprehension of the information, but these exclude any element of a
promotional nature.
2.2. Mock-ups and specimens
Mock-ups and specimens of the outer and immediate packaging together with the package leaflet must
be submitted by the applicant/MAH to the EMA for review, before commercialisation of the medicinal
product.
A ‘mock-up’ is a copy of the flat artwork design in full colour, presented so that, following cutting and
folding where necessary, it provides a replica of both the outer and immediate packaging so that the
three dimensional presentation of the label text is clear.
Checking process of mock-ups and specimens of outer/immediate labelling and
package leaflets of human medicinal products in the centralised procedure
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A ‘specimen’ is a sample of the actual printed outer and immediate packaging materials and package
leaflet (i.e. the sales presentation).
2.3. Principles applied to the checking of mock-ups and specimens
The mock-ups and specimens checking process is based on the following general principles:
•
The EMA, through the translations checking policy, ensures that high-quality product information in
all EU languages, as prepared by the MAH and checked by the Member States prior to the granting
of the MA, is included in Commission Decisions on centrally authorised medicinal products.
•
MAHs are responsible for the correct implementation of the agreed product information texts in
their printed packaging materials, in line with the Commission Decision and relevant EU legislation.
•
The EMA does not perform a detailed linguistic check of mock-ups and specimens, but rather a
general check from the viewpoint of readability in order to contribute to the safe use of medicines.
•
The EMA does not keep a full set of specimens of the whole product range covering all Member
States, but keeps on file only example of mock-ups and specimens of printed packaging materials
of all centrally authorised products, as reference samples of the whole product range marketed in
the EU.
•
The EMA can, at any time, request specific specimens from the MAH for review (e.g. further to a
safety-related or product defect issue).
The proposed outer and immediate labelling and package leaflet will be reviewed for compliance with
the requirements outlined in Directive 2001/83/EC. Detailed reviews of the content of the labelling and
leaflet proposals and their translations will take place during the scientific assessment and linguistic
review of the application.
Presentation of the information in terms of print size, colour and layout is an important factor in overall
‘readability’ of labelling and leaflet, and this will in particular be checked on the submitted mock-ups
and specimens. Such a general, so-called ‘readability’ check 2 of mock-ups and specimens focuses on
overall layout and design of the packaging and leaflet, font-sizes, positioning of text, use of colours,
pictograms, ‘blue box’ location, differentiation between strengths, presentation of critical labelling
information etc.
As the EMA is requiring only specimen examples of the whole range of authorised product
presentations to be submitted (see section 3 for details), it is understood that these specimen
examples will be representative of all other presentations, except for the elements directly related to
the difference in presentation concerned (e.g. different number of tablets, different EU number).
The check is performed by dedicated EMA staff in close liaison with the product team leader and the
QRD secretariat. In case of comments on the specimens, the EMA will discuss the best and feasible
corrective action with the applicant/MAH, taking into account the nature and amount of issues
identified.
If, however, major safety issues are identified, EMA may request revised specimens to be provided for
review before marketing or may even request a recall of already marketed products.
2
This is not the “patient group consultation” of the package leaflet which is to be performed by applicants/MAHs according to Article
59(3) of Directive 2001/83/EC.
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2.4. Submission of mock-ups and specimens
For any questions on the checking process or to discuss upcoming mock-ups and/or specimen
submissions, please contact the EMA by e-mail at [email protected].
Mock-ups:
Where required, mock-ups must be included in module 1.3.2 of the application dossier or should be
sent directly to [email protected], as applicable.
In case of comments on the mock-ups, responses and/or updated mock-ups should be submitted, as
applicable, to the EMA ([email protected]) prior to the production or launch of the
medicinal product.
When submitting responses to the EMA, applicants may use the mock-ups and specimens responses
form (see annex 1).
Specimens:
All specimens, including renewals, must be submitted by post using the specimen submission form
(see annex 2), to the following address:
Mock-ups and specimens
European Medicines Agency
30 Churchill Place
Canary Wharf
London E14 5EU
United Kingdom
Applicants/MAHs must declare in the specimen submission form that:
•
The specimen is in compliance with the relevant approved product information texts.
•
The specimen is printed in the official language(s) of the Member State(s) where it will be
marketed.
•
The ‘blue box’ is in line with the relevant national requirements, as outlined in the current
Guideline on Packaging Information. The local representative, when mentioned in the ‘blue box’, is
identical to the one mentioned in the package leaflet.
•
Text in ‘Braille’ is embossed correctly on the pack, if applicable (in line with section 16 of the outer
labelling text and in line with relevant national requirements of the Member State(s) concerned).
In case of comments on the specimens, responses and/or updated mock-ups should be submitted, as
applicable, to the EMA ([email protected]) prior to the production or launch of the
medicinal product.
When submitting responses to the EMA, applicants may use the mock-ups and specimens responses
form (see annex 1).
Checking process of mock-ups and specimens of outer/immediate labelling and
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3. The mock-up and specimen checking process
The following requirements and checking process will apply, as summarised in annex 3:
3.1. New marketing authorisation applications and extensions applications
Mock-ups:
Based on Article 8.3 (j) of Directive 2001/83/EC, applicants must provide at submission an English and
multi-lingual (‘worst-case’) colour mock-up of outer and immediate packaging for each pharmaceutical
form in each container type (e.g. blister, bottle, vial, pen) in the smallest pack-size for new marketing
authorisation applications. Mock-ups must also be provided for each strength or for each different total
content per total volume, when the strength is expressed as concentration per unit volume (x mg/ml).
For extension applications, this will only concern the new strength, pharmaceutical form and/or route
of administration applied for.
Mock-ups of package leaflets are not required at submission, but may be provided voluntarily in the
application or at a later stage during the procedure.
At the initial submission applicants should, as far as possible, submit mock-ups which are considered
final drafts.
In the validation letter, the EMA may include provisional comments on the mock-ups, which the
applicant should take into account when further developing its packaging proposals.
The mock-ups will subsequently be reviewed in detail by the EMA in parallel to the scientific
assessment, and any mock-up comments will be sent together with the PIQ comments on the EN
product information by day 120 3.
In case of comments or in case the applicant changes the overall design, revised mock-ups should be
submitted as part of the answers to the list of questions at day 121. Comments on the (revised) mockups will be sent together with the QRD comments (day 155).
In case of a QRD sub-group meeting at day 165, EMA could take the opportunity to also discuss the
draft mock-ups to complement the product information review.
At day 181, EMA will make sure that any outstanding comments made at Day 155 are solved prior to
the opinion.
Submission of further mock-ups for review is not required after adoption of the Opinion. However, EMA
would be willing to perform an additional review of updated mock-ups in the post-opinion phase, if
requested by applicants prior to specimen printing.
3
See ‘The linguistic review process of product information in the centralised procedure – human’
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004182.pdf
Checking process of mock-ups and specimens of outer/immediate labelling and
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Specimens:
One set of relevant example specimen examples of outer and immediate packaging and package
leaflet should be provided to the EMA (mock-ups and specimens) for review at the latest 15 working
days before launch for each strength or for each different total content per total volume [when the
strength is expressed as concentration per unit volume (x mg/ml)], pharmaceutical form and container
type (‘product presentation’):
•
before their first marketing in the EU;
•
before marketing as a multi-lingual pack in the EU;
•
when any other multi-lingual pack is introduced which has a greater number of languages than the
multi-lingual pack(s) previously reviewed.
For example: MAH plans to launch the newly approved product in Germany as the first MS –> German
specimens are to be provided to the EMA. The MAH subsequently launches the product in the UK and
Ireland –> no specimens to be provided. The MAH next launches the product in Italy and Spain, using
a combined ES/IT language pack –> specimens to be provided to the EMA. Any further specimens will
only have to be provided if the packs contain more than 2 languages.
Specimens can be sent to the EMA before the final Commission Decision is granted. Applicants should
allow sufficient time for the review process of specimens, including any subsequent changes which
may exceptionally have to be introduced to the specimens before launch.
Specimens for one pack-size are sufficient; in case of multiple pack-sizes being launched at the same
time, EMA would prefer receiving specimens of the smallest pack-size. In case (first) marketing takes
place in more than one Member State, it is not necessary to send several single-language and/or
multi-lingual specimens in relation to different Member States; specimens for one of such Member
States are sufficient (e.g. 1 set of specimens with 1 language, 1 set of specimens with 2 languages, 1
set of specimens with 5 languages….).
As such, the EMA will receive and review at least one set of specimens for each different product
presentation before their first introduction on the EU market, as well as any relevant ‘worst-case’
multi-lingual specimens.
The EMA will perform a general check (see section 2.3) within 15 working days, and will check if any
previous comments on mock-ups/specimens have been duly implemented. The applicant will be
informed about the outcome of the check.
In case of comments on the specimens, the MAH should submit responses and/or updated mock-ups,
as applicable, to the EMA ([email protected]) prior to the launch of the medicinal product.
EMA will discuss the best and feasible corrective action with the MAH, taking into account the nature
and amount of issues identified. EMA will endeavour to provide such feedback as soon as possible and
taking into consideration the launch plan of the medicinal product, as applicable.
3.2. Renewals
Mock-ups:
No mock-ups are required at the time of renewal of the marketing authorisation.
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Specimens:
At renewal, EMA will perform a new check of the specimens across all marketed product presentations.
Relevant specimen examples should be provided to the EMA (see section 2.4 for the submission
details), for each strength, pharmaceutical form and container type in the smallest marketed packsize. Ideally multi-lingual specimens should be provided but, if not available, a single-language
specimen may be submitted. As such the EMA will receive and check at least one example specimen of
the whole range of marketed product presentations after 5 years, in one submission.
The EMA will perform a general check (see section 2.3) in parallel to the renewal assessment
procedure within 25 working days, and will check if any previous comments on specimens have been
duly implemented. The applicant will be informed about the outcome of the check.
In case of comments on the specimens, the MAH should submit responses and/or updated mock-ups,
as applicable, to the EMA ([email protected]) at the latest 15 working days prior to the
finalisation of the renewal procedure. EMA will discuss the best and feasible corrective action with the
MAH, taking into account the nature and amount of issues identified. EMA will endeavour to provide
such feedback within 15 working days.
Note:
If the MAH plans to change the overall design and readability of the labelling and/or package leaflet
around the time of renewal, submission of specimens of the “old” product design will not be necessary.
In such a case, the same principles as in section 3.4 will apply. This approach should however be
discussed with the product team leader in advance of the renewal submission (e.g. at the renewal presubmission meeting).
3.3. Transfer of MAH
Mock-ups:
According to point 6 in the Annex to Regulation (EC) No 2141/96 on transfers of centrally authorised
medicinal products, mock-ups are to be included in the transfer application. Ideally, applicants must
provide at submission an English and multi-lingual (‘worst-case’) colour mock-up of outer and
immediate packaging for each pharmaceutical form in each container type (e.g. blister and bottle, vial
and pen) in the smallest pack-size. If not available, relevant example mock-ups of the marketed
presentation may be submitted instead.
If the transfer only affects the MAH details on the packaging and package leaflet without any impact on
the overall design, a declaration stating that only the details of the MAH have been modified and that
such changes will be introduced in all product presentations should be included in module 1.3.2 of the
application dossier.
EMA will review the mock-ups in parallel to the handling of the transfer procedure. If EMA has any
comments on the mock-ups; these will be sent to the MAH within 15 working days from the start of
the procedure.
In case of comments on the mock-ups, the MAH should submit responses and/or updated mock-ups,
as applicable, to the EMA ([email protected]) prior to the specimen printing. EMA will
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discuss the best and feasible corrective action with the MAH, taking into account the nature and
amount of issues identified. EMA will endeavour to provide such feedback as soon as possible and
taking into consideration the production plan of the medicinal product, as applicable.
Specimens:
Only in case the transfer has an impact on the overall design, relevant revised example specimens
should be provided to the EMA by the new MAH, in line with the requirements for new applications and
extensions (see section 3.1).
If the transfer only affects the MAH details on the packaging and package leaflet without any impact on
overall design, specimens are not required.
The EMA will perform a general check (see section 2.3) within 15 working days, and will check if any
previous comments on specimens have been duly implemented. The applicant will be informed about
the outcome of the check.
In case of comments on the specimens, the MAH should submit responses and/or updated mock-ups,
as applicable, to the EMA ([email protected]) prior to the launch of the medicinal product.
EMA will discuss the best and feasible corrective action with the MAH, taking into account the nature
and amount of issues identified. EMA will endeavour to provide such feedback as soon as possible and
taking into consideration the launch plan of the medicinal product, as applicable.
3.4. Other post-authorisation procedures
Mock-ups:
In principle, no mock-ups are to be provided in case of post-authorisation procedures other than
extensions and transfers applications affecting the overall layout.
However, where the overall design and readability of the outer and immediate packaging and/or
package leaflet is affected as part of a post-authorisation procedure, the need for the provision of
mock-ups should be discussed with the EMA ([email protected]) on a case-by-case basis
(e.g. mock-ups would be required when proposing a new corporate design of packs, a new container
type, use of different colours, major changes in layout, a new pack size smaller than the current
approved range, but not e.g. when only limited new text is added in a leaflet section).
In case the submission of mock-ups is required, the relevant example mock-ups would need to be
included in the module 1.3.2 of the application dossier.
The EMA will perform a general check (see section 2.3) within 15 working days. The applicant will be
informed about the outcome of the check.
In case of comments on the mock-ups, the MAH should submit responses and/or updated mock-ups,
as applicable, to the EMA ([email protected]) prior to the specimens printing. EMA will
discuss the best and feasible corrective action with the MAH, taking into account the nature and
amount of issues identified. EMA will endeavour to provide such feedback as soon as possible and
taking into consideration the production plan of the medicinal product, as applicable.
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Specimens:
In principle, no specimens are to be provided in case of post-authorisation procedures other than
extensions, renewals and transfers.
However, where the overall design and readability of the outer and immediate packaging and/or
package leaflet is affected (e.g. when proposing a new corporate design of packs, a new container
type, use of different colours, major changes in layout, a new pack size smaller than the current
approved range, but not e.g. when only limited new text is added in a leaflet section), the need for the
provision of specimens should be discussed with the EMA on a case-by-case basis.
In case specimens are required, in principle only one relevant example (multi-lingual if possible) would
need to be sent to the EMA at the latest 15 working days before marketing. However, depending on
the nature and extent of the change(s) concerned, additional specimens may be required by the EMA.
The EMA will perform a general check (see section 2.3) within 15 working days, and will check if any
previous comments on mock-ups and/or specimens have been duly implemented. The applicant will be
informed about the outcome of the check.
In case of comments on the specimens, the MAH should submit responses and/or updated mock-ups,
as applicable, to the EMA ([email protected]) prior to the launch of the medicinal product.
EMA will discuss the best and feasible corrective action with the MAH, taking into account the nature
and amount of issues identified. EMA will endeavour to provide such feedback as soon as possible and
taking into consideration the launch plan of the medicinal product, as applicable.
Notes:
•
In the case of a safety issue arising from defective product labelling (e.g. errors in
handling/dosing instructions in the PL) and affecting marketed batches of a product, this will be
handled according to the procedure for Dealing with Reports of Defective Medicinal Products
(SOP/INSP/2018), with involvement of the EMA staff dedicated to the review of mock-ups and
specimens, product team leader and QRD secretariat.
•
MAHs are reminded that all proposed changes to the text of the labelling or the package
leaflet (i.e. changes to Annex IIIA and IIIB), which are not connected with the SmPC,
and which are not part of any other regulatory procedure, should be notified to the EMA
according to Art 61(3) of Directive 2001/83/EC.
•
For any non-textual changes to the labelling and package leaflet introduced outside any
regulatory procedure, where the overall design and readability of the outer and immediate
packaging and/or package leaflet is significantly affected, the principles for the review of mock-ups
and specimens, as outlined in the paragraphs above, will also apply. However, in this case the
relevant mock-ups should be sent by e-mail to the EMA ([email protected]), copying
the product team leader, together with the relevant background information about the change.
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Annex 1 – Mock-ups and specimens responses form
Mock-ups and specimens responses form
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Mock-ups and specimens responses form
For applicants when submitting responses/revised mock-ups and/or
specimens to the European Medicines Agency
Product name
:
Active substance/common
name
:
Procedure number
:
Status of the application 4
:
Date submission
of responses
:
Applicant’s details 5
:
All comments implemented
:
Tick the box if appropriate
If not, a justification should be provided stating why certain comments are not reflected in the revised
version of the mock-ups/specimens. Please indicate, as presented in the table included in the next
page, the labelling item (outer carton, vial label, blister foil etc.) to which the comment relates
together with an alternative proposal.
4
5
Only for new marketing authorisation and line extensions applications: day 121, day 181, pre-opinion etc.
Including details of applicant’s contact person i.e. name, tel. fax, e-mail etc.
Mock-ups and specimens responses form
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•
<Please specify labelling item>>
EMA comments
Mock-ups and specimens responses form
EMA/305821/2006
Alternative proposal
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Annex 2 – Specimen submission form
Specimen submission form
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Specimen submission form
Product (invented) name:
Marketing authorisation holder:
Pharmaceutical
Strength
form
Container type
Procedure
(e.g. vial, pen
Procedure
Type of specimen
Member
number
submitted
State(s)(e.g.
etc.)
OC
LAB
PL 6
DK/FI/SE)
Choose from list
Choose from list
Choose from list
Choose from list
Choose from list
Choose from list
Choose from list
Choose from list
Notes to the EMA (e.g. description of changes affecting the layout or readability compared to the last reviewed specimens):
The undersigned declares that:
The specimens are in compliance with the relevant approved product information.
The specimens contain (all) the relevant official language(s) of the Member State(s) 7 where they will be marketed.
The ‘blue box(es)’ is(are) in line with the relevant national requirements, as outlined in the current Guideline on Packaging Information. The local
representative when mentioned in the ‘blue box’, is identical to the one mentioned in the package leaflet.
Braille (if applicable): The Braille is embossed correctly on the pack, is in line with section 16 of the outer labelling text, and in line with relevant national
requirements of the Member State(s) concerned (where applicable).
Contact details:
Signature:
6
7
Date:
OC: Outer carton, LAB: Immediate labelling/blister; PL: Package leaflet.
Except for Malta, where packs can be marketed in English and/or Maltese.
Specimen submission form
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Annex 3 - Summary of mock-up and specimen submission
requirements
(Please refer to guideline text for full details)
Summary of mock-ups and specimen submission requirements
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New marketing authorisation and extensions applications
When to submit
What to submit
When checked
Day 0 (submission
Mock-ups
During
of the application
Colour mock-ups of outer and immediate packaging
validation
for each pharmaceutical form, each strength [or for each
PIQ review
different total content per total volume when the strength is
expressed per concentration per unit volume (x mg/ml)] in
each container type (e.g. blister, bottle, vial, pen …) in the
smallest pack-size.
Day 121
•
1 EN mock-up.
•
1 multi-lingual mock-up (“worst-case”).
•
Mock-ups of package leaflet may be included (optional).
Mock-ups
•
QRD review
Revised mock-ups (if applicable).
•
Day 165
QRD subgroup
meeting (if
applicable)
Day 181
Mock-ups
Pre-opinion
Revised mock-ups (if applicable).
At the latest 15
Specimens
Within 15
working days
One set of specimens of printed outer and immediate
working days
before marketing
packaging materials and package leaflet for each strength [or
for each different total content per total volume when the
strength is expressed per concentration per unit volume (x
mg/ml)] and each pharmaceutical form in each container type
need to be provided to the EMA:
•
when first marketed in the EU;
•
when first marketed as a multi-lingual pack in the EU;
•
when any other multi-lingual pack is marketed with a
higher number of languages than the multi-lingual pack(s)
previously reviewed.
Prior to launch of
Specimens
Timeline to be
the medicinal
In case of comments on the specimens, the MAH should submit
adjusted on the
product
responses and/or updated mock-ups, as applicable, to EMA
basis of the
([email protected]).
intended launch
date
Summary of mock-ups and specimen submission requirements
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Renewals
When to submit
What to submit
When checked
At the same time
Specimens
Within 25
as the submission
One set of specimens of printed outer and immediate
working days
of the renewal
packaging materials and package leaflet for each strength and
application (i.e. at
each pharmaceutical form in each container type in the
least 6 months
smallest marketed pack-size:
before MA expiry)
•
1 multi-lingual example specimen (“worst-case”) for each
of the above, or
•
if not available, a single-language specimen.
At the latest 15
Specimens
Within 15
working days
In case of comments on the specimens, the MAH should submit
working days
prior to the
responses and/or updated mock-ups, as applicable, to the EMA
finalisation of the
([email protected]).
renewal procedure
Transfers
When to submit
What to submit
When checked
Submission of
Mock-ups
Within 15
application
Colour mock-ups of outer and immediate packaging
working days
for each pharmaceutical form in each container type (e.g.
from start of
blister, bottle, vial, pen …) in the smallest pack-size:
procedure
•
1 EN mock-up
•
1 multi-lingual mock-up (“worst-case”)
Should English and/or multi-lingual (‘worst-case’) are not
marketed, relevant example mock-ups of the marketed
presentation may be submitted instead.
If the transfer only affects the MAH details on the
packaging and package leaflet without any impact on the
overall design, a declaration stating that only the details of the
MAH have been modified and that such changes will be
introduced in all product presentations should be included in
module 1.3.2 of the application dossier.
If EMA has any comments on the mock-ups; these will be sent
to the MAH within 15 working days from the start of the
procedure.
Prior to the
Mock-ups
Timeline to be
specimens
MAHs should submit responses and/or updated mock-ups to
adjusted on the
printing
the EMA ([email protected]).
basis of the
intended
production date
Summary of mock-ups and specimen submission requirements
EMA/305821/2006
Page 17/19
When to submit
What to submit
When checked
At the latest 15
Specimens
Within 15
working days
Only in case the transfer has an impact on the overall
working days
before marketing
design, relevant revised example specimens should be
provided to the EMA by the new MAH.
One set of specimens of printed outer and immediate
packaging materials and package leaflet for each strength and
each pharmaceutical form in each container type:
•
when first marketed in the EU,
•
when first marketed as a multi-lingual pack (if different
from the first specimens sent to EMA),
•
when any other multi-lingual pack is marketed with a
higher number of languages than the multi-lingual pack(s)
previously reviewed.
If the transfer only affects the MAH details on the packaging
and package leaflet without any impact on overall design,
submission of specimens is not required.
Prior to the launch
Specimens
Timeline to be
of the medicinal
In case of comments on the specimens, the MAH should submit
adjusted on the
product
responses and/or updated mock-ups, as applicable, to the EMA
basis of the
([email protected]).
intended launch
date
Summary of mock-ups and specimen submission requirements
EMA/305821/2006
Page 18/19
Other post-authorisation procedures
When to submit
What to submit
When checked
Submission of
Mock-ups
Within 15
application
Only when the overall design and readability of the outer &
working days
immediate packaging and/or package leaflet is affected:
•
Submission of mock-ups should be discussed with the EMA
(on a case-by-case basis).
Prior to the
Mock-ups
Timeline to be
specimens
In case of comments on the mock-ups, the MAH should submit
adjusted on the
printing
responses and/or updated mock-ups, as applicable, to the EMA
basis of the
([email protected]).
intended
production date
At the latest 15
Specimens
Within 15
working days
Only when the overall design and readability of the outer &
working days
before marketing
immediate packaging and/or package leaflet is affected:
•
Submission of specimens should be discussed with the EMA
•
In principle only one relevant set of example specimens
(on a case-by-case basis).
(multi-lingual if possible) would be required. However,
depending on the nature and extent of the change(s)
concerned, additional specimens may be required by the
EMA
Prior to the launch
Specimens
Timeline to be
of the medicinal
MAHs should submit responses and/or updated mock-ups to
adjusted on the
product
the EMA ([email protected]).
basis of the
intended launch
date
Summary of mock-ups and specimen submission requirements
EMA/305821/2006
Page 19/19